# K180204: CranioMaxillofacial Fixation (CMF) System - CMF Visionare

- Pathway: 510(k) (Traditional)
- Applicant: Visionare, LLC
- Decided: Dec 28, 2018 after 338 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980512 (1998). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102641: Mini and  Micro Fragments Reconstruction System-Neoface, Neoortho Produtos Ortopedicos S/A (2010) Summary page 4.

## Most influential descendants
- K182758: MCI - CMF System (2019), 0 descendants of its own
- K182609: Delphos Implants Rigid Fixation System (2019), 0 descendants of its own

## Indications for use
CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Source page: https://510kreport.com/device/K180204
Methodology: https://510kreport.com/methodology